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Production Scientist

3 months ago

Indianapolis, United States MiraVista Diagnostics Full time

MiraVista Diagnostics (MVD) is a clinical reference laboratory with specific focus on fungal pathogen detection in humans and animals. We are seeking a high performing individual with immunoassay manufacturing experience. The Production Scientist will be responsible for formulation of chemical buffers, purifying antibodies, labeling antibodies with detector molecules, assembling IVD/LDT kits and method verification and validation. This individual will plan and schedule day to day manufacturing and process validations of products under ISO, CE, and FDA regulations.


Summary of Responsibilities

Responsibilities include formulation of buffers, purifying antibodies, labeling antibodies with detector molecules, assembling IVD/LDT kits and method verification and validation.

Responsible for compliance with MiraVista Diagnostics’ policies and procedures.

Essential Duties and Responsibilities:

· Mentor employees by performing supplemental technical guidance and on the job training

· Help to identify and correct equipment, process, and safety issues in the lab

· Establish and maintain DMRs, SOPs, Manufacturing Instructions, and other manufacturing documents. Ensure adherence to cGMP, safety policies and company’s procedures.

· Participate on project teams as Technical Lead and Manufacturing representative and lead Design Transfer activities.

· Develop and execute process verifications and validations.

· Effectively interact with staff in R&D, QA, QC, Regulatory Affairs and Clinical departments.

· Understand and support the establishment of purification and analytical methods for characterizing proteins and conjugates.

· Understand and apply knowledge of a variety of immunoassay manufacturing processes, including protein conjugation, plate and bead coating chemistries, data analysis to develop robust and scalable production processes.

· Be part of team tasked with improvement/development of diagnostic products.

· Equipment function checks and related functional verification with data entry for various pieces of laboratory equipment. Laboratory equipment preventative maintenance tasks.

Ensure work is aligned with all relevant quality requirements.


Qualifications

· Minimum BS in Life Sciences or a related science field; 2 years of Experience in diagnostic industry is preferred.

· Experience with FDA/GMP regulated medical device manufacturing or similar industry.

· Knowledge of immunoassay chemistries, PCR methods, IVD product development and manufacturing processes, and equipment validations.

· Proven ability to successfully transfer IVD products from R&D into production.

· Experience in: GMP documents (Master Device Records, Device History Records, SOP's).

· Experience with electronic QMS and manufacturing ERP systems.

· Good organizational skills.